Heart drug tested as migraine shield in small trial
NCT ID NCT04853797
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at whether ivabradine, a medicine used for heart conditions, could stop migraines triggered by another drug called levcromakalim. 37 adults with migraine without aura took part. The goal was to see if ivabradine could reduce the number of migraines caused by the trigger, helping researchers understand how migraines start.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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37 people
The number who actually took part.
- Started
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May 2021
- Finished
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Jul 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Be able to give voluntary written informed consent to participate. * Have a diagnosis of episodic migraine without aura according to The International Classification of Headache Disorders 3rd Edition. * Be in good general health and without any cardio- or cerebrovascular diseases, psychiatric disorders or other severe comorbidities. * Be 18-60 years of age. * Have a weight between 50-100 kg. * Have a normal standard resting 12-lead ECG at the screening visit with heart rate (HR) ≥ 60 bpm (the inclusion criterium of HR ≥ 60 bpm at screening has previously been used in studies with dosages of ivabradine up to 20 mg as single and multiple doses with no significant adverse events). * Be without any chronic use of medicine. * Have a negative urine-human chorionic gonadotropin (hCG) test at the screening visit if they are female of childbearing potential. Exclusion Criteria: * Suffer from tension type headache, as defined by the The International Classification of Headache Disorders 3rd Edition, more than five days a month on average in the last year. * Are diagnosed with any primary headache disorder apart from migraine without aura as de-fined in The International Classification of Headache Disorders 3rd Edition (relating to tension type headache, see above). * Suffer from any headache 48 hours prior to the start of the experiment or any migraine 72 hours prior to the start of the experiment. * Are allergic to ivabradine or levcromakalim. * Are lactose intolerant (due to Ivabradine tablets containing lactose). * Have a daily intake of any medicine other than oral contraception or use of drugs or other ed-ibles/beverages with potential serious interactions with ivabradine * Have a history of personal/familial or clinical signs of: cardiovascular and cerebrovascular disease (Long QT Syndrome, Cardiac dysrhythmia, Bradycardia, i.e. a resting heart rate of \< 60 bpm at screening, Amnestic information or clinical signs of hyper- or hypotension (Hypertension (systolic blood pressure \> 150 mmHg and / or diastolic blood pressure \> 100 mmHg)/Hypotension (systolic blood pressure \< 90 mm Hg and / or diastolic blood pressure \< 50 mmHg)), Heart failure (NYHA II or higher)); Psychiatric conditions; Drug abuse of any kind; Smoking; Other comorbidities or clinical signs of diseases of any kind considered by the investigating physician to make the participant ineligible because of safety concerns). * Are pregnant, breastfeeding or not using appropriate contraception. * Do not want any information on significant pathological findings in the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Danish Headache Center
Glostrup Municipality, 2600, Denmark
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Danish Headache Centre, Rigshospitalet-Glostrup
Glostrup, Region Sjælland, 2600, Denmark
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